Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials

Accepted 9 February 2017Objective: To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials. Setting: Tertiary cancer referral hospitals in three state capital cities in Australia. Participants: 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial. Interventions: We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial. Primary and secondary outcomes: Questionnaires were completed at baseline and within 3â €..weeks of deciding on treatment trial participation. Main outcome measure: scores on the Quality of Informed Consent questionnaire (QuIC). Results: 88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups. Conclusions: Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006. Trial registration number: Results, ACTRN12606000214538.Martin H N Tattersall, Michael Jefford, Andrew Martin, Ian Olver, John F Thompson, Richard F Brown, Phyllis N Buto

Dreaming of drams: Authenticity in Scottish whisky tourism as an expression of unresolved Habermasian rationalities

In this paper, the production of whisky tourism at both independently owned and corporately owned distilleries in Scotland is explored by focusing on four examples (Arran, Glengoyne, Glenturret and Bruichladdich). In particular, claims of authenticity and Scottishness of Scottish whiskies through commercial materials, case studies, website-forum discussions and 'independent' writing about such whisky are analysed. It is argued that the globalisation and commodification of whisky and whisky tourism, and the communicative backlash to these trends typified by the search for authenticity, is representative of a Habermasian struggle between two irreconcilable rationalities. This paper will demonstrate that the meaning and purpose of leisure can be understood through such explorations of the tension between the instrumentality of commodification and the freedom of individuals to locate their own leisure lives in the lifeworld that remains. © 2011 Taylor & Francis

“It Is What You Make It”: Opportunities Arising from the Unique Roles of Honors College Deans

Grounded in the shared experiences of three current honors college deans and in comprehensive interviews with another two dozen honors deans at diverse institutions of higher education across the U.S., this chapter argues that the uniqueness of honors college dean roles and work can—and indeed should—lead to innovative and transformative change and improved student experiences, outcomes, and success, not only in honors colleges and within the scope of honors education, but across entire institutions. Ultimately the chapter contends that, while there can be manifold frustrations in running an honors college, the position of honors dean is one of the best administrative jobs in academia and creates tremendous opportunities for transformational change for leaders who are energetic and agile in their approaches

Anti-plasmodial polyvalent interactions in Artemisia annua L. aqueous extract – possible synergistic and resistance mechanisms

Artemisia annua hot water infusion (tea) has been used in in vitro experiments against P. falciparum malaria parasites to test potency relative to equivalent pure artemisinin. High performance liquid chromatography (HPLC) and mass spectrometric analyses were employed to determine the metabolite profile of tea including the concentrations of artemisinin (47.5±0.8 mg L-1), dihydroartemisinic acid (70.0±0.3 mg L-1), arteannuin B (1.3±0.0 mg L-1), isovitexin (105.0±7.2 mg L-1) and a range of polyphenolic acids. The tea extract, purified compounds from the extract, and the combination of artemisinin with the purified compounds were tested against chloroquine sensitive and chloroquine resistant strains of P. falciparum using the DNA-intercalative SYBR Green I assay. The results of these in vitro tests and of isobologram analyses of combination effects showed mild to strong antagonistic interactions between artemisinin and the compounds (9-epi-artemisinin and artemisitene) extracted from A. annua with significant (IC50 <1 μM) anti-plasmodial activities for the combination range evaluated. Mono-caffeoylquinic acids, tri-caffeoylquinic acid, artemisinic acid and arteannuin B showed additive interaction while rosmarinic acid showed synergistic interaction with artemisinin in the chloroquine sensitive strain at a combination ratio of 1:3 (artemisinin to purified compound). In the chloroquine resistant parasite, using the same ratio, these compounds strongly antagonised artemisinin anti-plasmodial activity with the exception of arteannuin B, which was synergistic. This result would suggest a mechanism targeting parasite resistance defenses for arteannuin B’s potentiation of artemisinin

Healthy living after cancer: a dissemination and implementation study evaluating a telephone-delivered healthy lifestyle program for cancer survivors

Background: Given evidence shows physical activity, a healthful diet and weight management can improve cancer outcomes and reduce chronic disease risk, the major cancer organisations and health authorities have endorsed related guidelines for cancer survivors. Despite these, and a growing evidence base on effective lifestyle interventions, there is limited uptake into survivorship care. Methods/Design: Healthy Living after Cancer (HLaC) is a national dissemination and implementation study that will evaluate the integration of an evidence-based lifestyle intervention for cancer survivors into an existing telephone cancer information and support service delivered by Australian state-based Cancer Councils. Eligible participants (adults having completed cancer treatment with curative intent) will receive 12 health coaching calls over 6 months from Cancer Council nurses/allied health professionals targeting national guidelines for physical activity, healthy eating and weight control. Using the RE-AIM evaluation framework, primary outcomes are service-level indicators of program reach, adoption, implementation/costs and maintenance, with secondary (effectiveness) outcomes of patient-reported anthropometric, behavioural and psychosocial variables collected at pre- and post-program completion. The total participant accrual target across four participating Cancer Councils is 900 over 3 years. Discussion: The national scope of the project and broad inclusion of cancer survivors, alongside evaluation of service-level indicators, associated costs and patient-reported outcomes, will provide the necessary practice-based evidence needed to inform future allocation of resources to support healthy living among cancer survivors.Elizabeth G. Eakin, Sandra C. Hayes, Marion R. Haas, Marina M. Reeves, Janette L. Vardy, Frances Boyle, Janet E. Hiller, Gita D. Mishra, Ana D. Goode, Michael Jefford, Bogda Koczwara, Christobel M. Saunders, Wendy Demark-Wahnefried, Kerry S. Courneya, Kathryn H. Schmitz, Afaf Girgis, Kate White, Kathy Chapman, Anna G. Boltong, Katherine Lane, Sandy McKiernan, Lesley Millar, Lorna O, Brien, Greg Sharplin, Polly Baldwin and Erin L. Robso

Efficacy and cost-effectiveness of an outcall program to reduce carer burden and depression among carers of cancer patients (PROTECT) : rationale and design of a randomized controlled trial

Published: 6 January 2014BACKGROUND: Carers provide extended and often unrecognized support to people with cancer. The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care, information and referral to appropriate psycho-social services. Secondary aims include estimation of changes in psychological health and quality of life. The study will determine whether the intervention reduces unmet needs among patient dyads. A formal economic program will also be conducted. METHODS/DESIGN: This study is a single-blind, multi-centre, randomized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients. A total of 230 carer/patient dyads will be recruited into the study; following written consent, carers will be randomly allocated to either the outcall intervention program (n = 115) or to a minimal outcall / attention control service (n = 115). Carer assessments will occur at baseline, at one and six months post-intervention. The primary outcome is change in carer burden; the secondary outcomes are change in carer depression, quality of life, health literacy and unmet needs. The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs. The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs. DISCUSSION: This study will contribute to our understanding on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers.Patricia M Livingston, Richard H Osborne, Mari Botti, Cathy Mihalopoulos, Sean McGuigan, Leila Heckel, Kate Gunn, Jacquie Chirgwin, David M Ashley and Melinda William

Priorities for multimorbidity management and research in cancer: a Delphi study of Australian cancer survivors, clinicians, and researchers.

PURPOSE: Multimorbidity is common in people with cancer and associated with increased complexity of care, symptoms, mortality, and costs. This study aimed to identify priorities for care and research for cancer survivors with multimorbidity. METHODS: A Delphi consensus process was conducted. Elements of care and research were based on Australia's National Strategic Framework for Chronic Conditions, a literature review, and expert input. In Round 1, health professionals, cancer survivors, and researchers rated the importance of 18 principles, 9 enablers, and 4 objectives. In Round 2, new elements were rated and all elements were ranked. RESULTS: In Round 1, all elements reached consensus for care delivery; three principles and one enabler did not reach consensus for research and were eliminated. One principle and two enablers were added, reaching consensus. In the final list, 19 principles, 10 enablers, and 4 objectives were included under care delivery; 14 principles, 9 enablers, and 4 objectives were included under research. For care delivery, principles of 'survivorship' and 'self-management' were ranked highest, and 'peer support' and 'technology' were the most important enablers. For research, 'survivorship' and 'coordinated care' were the highest-ranked principles, with 'peer support' and 'education' the most important enablers. CONCLUSION: Most elements apply to the general population and cancer survivors; however, additional elements relevant to survivorship need consideration when managing multimorbidity in cancer survivors. IMPLICATIONS FOR CANCER SURVIVORS: Chronic disease frameworks should be more inclusive of issues prioritised by people with, managing, or researching cancer through interdisciplinary approaches including acute and primary care